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Clinical Policy Bulletin:
Electrical Stimulation for Nausea, Vomiting and Motion Sickness (PrimaBella and ReliefBand)
Number: 0676


Policy

  1. Aetna considers transcutaneous electrical acupoint stimulation (prescription version ReliefBand devices) medically necessary for the treatment of post-operative nausea and chemotherapy-induced nausea that is unresponsive to antiemetics and other conservative therapies.  

  2. Aetna considers transcutaneous electrical acupoint stimulation (prescription version PrimaBella or ReliefBand devices) medically necessary for the treatment of hyperemesis gravidarum that is unresponsive to other conservative medical therapy (e.g., change in diet, ginger capsules, vitamin B6).

  3. Aetna considers transcutaneous electrical acupoint stimulation (prescription version ReliefBand devices) experimental and investigational for the prevention of motion sickness because its effectiveness for this indication has not been established. 

Note: Aetna does not cover over-the-counter disposable ReliefBand devices, which are used for the treatment of motion sickness, because they do not meet Aetna’s definition of durable medical equipment.



Background

The ReliefBand (Neurowave Medical Technologies, Chicago, IL) is a watch-like device worn on the ventral side of the wrist.  When activated, the device emits a low-level electrical current across 2 small electrodes on its underside, stimulating the median nerve (an acupuncture point).  The ReliefBand offers 5 stimulation levels from the rotary dial that one can control to provide maximum comfort and relief.  The non-invasive and drug-free ReliefBand is available by prescription for the treatment of nausea and vomiting (NV) due to pregnancy (PrimaBella, Alaven Pharmaceutical LLC, Marietta, GA), chemotherapy-induced NV, post-operative nausea and vomiting (PONV), and over-the-counter for the treatment of motion sickness.

Studies have shown that the ReliefBand is effective in treating chemotherapy-induced NV and as effective as antiemetic medications in managing NV following surgery. 

Lee and Done (1999) evaluated the effectiveness of non-pharmacologic techniques to prevent post-operative PONV by systematic review.  These studies included acupuncture, electroacupuncture, transcutaneous electrical nerve stimulation, acupoint stimulation, and acupressure.  The authors concluded that non-pharmacologic techniques were equivalent to commonly used antiemetic drugs in preventing vomiting after surgery.  Non-pharmacologic techniques were more effective than placebo in preventing NV within 6 hours of surgery in adults, but there was no benefit in children.

In a single-center, randomized, double-blind, placebo- and sham-controlled study, White et al (2002) compared the effectiveness of the ReliefBand to ondansetron when utilized alone or in combination for preventing PONV following plastic surgery (n = 120).  Patients were randomly assigned to 3 prophylactic antiemetic treatment regimens with routine low-dose droperidol prophylaxis: (i) ondansetron (n = 40): 4 mg intravenous (I.V.) ondansetron and a sham ReliefBand; (ii) acustimulation (n = 40): 2 ml I.V. saline and an active ReliefBand; and (iii) combination (n = 40): 4 mg I.V. ondansetron and an active ReliefBand.  The incidences of PONV, as well as the need for "rescue" antiemetics, were determined at specific time intervals for up to 72 hours after surgery.  The outcome variables assessed included recovery times, quality of recovery score, time to resumption of normal diet, and patient satisfaction with the prophylactic antiemetic therapy.  Use of the ReliefBand in combination with ondansetron significantly reduced nausea (20 versus 50 %), vomiting (0 versus 20 %), and the need for rescue antiemetics (10 versus 37 %) compared with ondansetron alone at 24 hours after surgery.  Furthermore, the ability to resume a normal diet (74 versus 35 %) within 24 hours after surgery was significantly improved when the ReliefBand was used to supplement ondansetron (versus ondansetron alone).  Finally, the quality of recovery (90 +/- 10 versus 70 +/- 20) and patient satisfaction (94 +/- 10 versus 75 +/- 22) scores were significantly higher in the combination group than the ondansetron group.  There were no significant differences between the ReliefBand and ondansetron when administered as adjuvants to droperidol for antiemetic prophylaxis. The authors concluded that the ReliefBand compared favorably to ondansetron when used for prophylaxis against PONV.

In a randomized, double-blind, placebo- and sham-controlled study, Coloma et al (2002) compared the ReliefBand with ondansetron (Zofran) for the treatment of PONV after outpatient laparoscopic surgery (n = 268).  All patients received antiemetic prophylaxis with metoclopramide, 10 mg I.V. or droperidol, 0.625 mg I.V. after induction of anesthesia.  A total of 90 patients developed PONV in the recovery units and were randomized to 1 of 3 treatment groups: (i) the ondansetron group received 4 mg I.V. ondansetron and a sham ReliefBand; (ii) the acustimulation group received 2 ml I.V. saline and a ReliefBand; and (iii) the combination group received 4 mg I.V. ondansetron and a ReliefBand.  A rescue antiemetic (10 mg I.V. metoclopramide) was administered only if the PONV symptoms persisted for 15 minutes or longer after initiating the treatment.  A blinded observer recorded the recovery times, emetic symptoms, rescue antiemetics, maximum nausea scores, complete response to study treatment, and time to achieve discharge criteria.  Post-discharge side effects, as well as patient satisfaction and quality of recovery scores, were assessed at 24 and 72 hours after surgery.  The combination group had a significantly higher complete response rate than the acustimulation group (73 versus 40 %).  In addition, fewer patients in the combination group experienced subsequent emetic events (8 compared to 18 in the acustimulation group).  However, there were no significant differences between the 3 groups with respect to patient satisfaction and quality of recovery scores. The authors concluded that acustimulation with the ReliefBand can be used as an alternative to ondansetron for the treatment of established PONV.

Habib and colleagues (2006) examined whether transcutaneous acupoint electrical stimulation with the ReliefBand can prevent NV during and after cesarean delivery under spinal anesthesia.  These investigators randomized 94 patients undergoing cesarean delivery with spinal anesthesia to receive the ReliefBand at the P6 point (active group) or an active ReliefBand applied to the dorsum of the wrist (sham control group).  The ReliefBand was applied 30 to 60 mins pre-operatively and left in place for 24 hours.  There was no statistically significant difference between the active and sham control groups in the incidence of intra-operative/post-operative nausea (30 % versus 43 %/23 % versus 41 %), vomiting (13 % versus 9 %/26 % versus 37 %), need for rescue antiemetics (23 % versus 18 %/34 % versus 39 %), or complete response (55 % versus 57 %/51 % versus 34 %).  There was also no difference between the 2 groups in nausea scores, number of vomiting episodes, or patient satisfaction with PONV management.

In a randomized controlled study (n = 105), White et al (2005) reported that acustimulation with the ReliefBand was most effective in reducing PONV and improving patients' satisfaction with their antiemetic therapy when it was administered after surgery.

However, a Cochrane review on acupuncture-point stimulation (needles, electrical stimulation, magnets, or acupressure) for chemotherapy-induced NV (Ezzo et al, 2006) reported that non-invasive electrostimulation appears unlikely to have a clinically relevant impact when patients are given state-of-the-art pharmacological antiemetic therapy.

PrimaBella™ (Alaven Pharmaceutical LLC, Marietta, GA) is a neuromodulatory device that utilizes the same technology as the ReliefBand.  It is intended for use in the treatment of NV due to pregnancy.  

Slotnick (2001) evaluated the safety and effectiveness of P-6 acustimulation for the relief of NV associated with early pregnancy in 41 patients.  Pre-treatment nausea severity, post-treatment nausea relief and device effectiveness were patient-rated using a 1 to 5 scale.  All neonates were evaluated for congenital abnormalities.  Pre-treatment nausea severity scores for treated patients averaged 4.2, with most severe and debilitating nausea rated 5.  Post-treatment device effectiveness averaged 4.2, with significant or complete relief rated 5.  Device ease of use averaged 4.3, with very easy to use rated 5.  No congenital abnormalities were found.  The authors concluded that because current pharmacologic treatments for nausea in early pregnancy are not consistent, efficacious or without un-wanted side effects or increased teratogenic risks, acustimulation of P-6 in pregnancy may prove to be a significant therapeutic alternative to current pharmacologic treatments for nausea in early pregnancy. 

The American College of Obstetrics and Gynecology (ACOG, 2004) recommend a step-wise approach to alleviating NV in pregnancy, beginning with prevention at the time of conception.  Two studies found that women who take a multi-vitamin at the time of conception were less likely to need medical attention for vomiting.  While there is little published evidence regarding the efficacy of dietary changes for prevention or treatment of NV of pregnancy, a small study showed that protein meals were more likely to relieve NV of pregnancy than carbohydrate and fatty meals.  Other conservative treatments recommended by ACOG included ginger capsules and electrical stimulation or acupressure at the P6 (or Neguian) point on the inside of the wrist.  Women with more complicated NV of pregnancy may need pharmacologic therapy.  While many conventional antiemetics have been used for NV of pregnancy, it is important to note that no drug has been approved by the FDA for the treatment of NV in pregnancy since Benedictine (an antiemetic no longer available in the U.S. but still widely used in Europe). 

In the largest controlled clinical study of the Relief Band for motion sickness published to date (n = 77), Miller and Muth (2004) examined whether acupressure and acustimulation can prevent motion sickness, taking into consideration whether or not the acupressure and acustimulation are administered properly.  These investigators found that neither band (the Acuband or the ReliefBand) nor placebo prevented the development of motion sickness, regardless of whether the bands were used correctly or incorrectly.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
97014
97032
HCPCS codes covered if selection criteria are met:
E0765 FDA approved nerve stimulator, with replaceable batteries, for treatment of nausea and vomiting
Other HCPCS codes related to the CPB:
G0283 Electrical stimulation (unattended), to one or more areas for indication(s) other than wound care, as part of a therapy plan of care
ICD-9 codes covered if selection criteria are met:
564.3 Vomiting following gastrointestinal surgery
643.00 - 643.93 Excessive vomiting in pregnancy
787.01 - 787.03 Nausea and vomiting
E933.1 Adverse effect of antineoplastic and immunosuppressive drugs
ICD-9 codes not covered for indications listed in the CPB:
994.6 Motion sickness
Other ICD-9 codes related to the CPB:
V47.3 Other digestive problems
V58.11 - V58.12 Encounter for antineoplastic chemotherapy and immunotherapy


The above policy is based on the following references:
  1. Ho CM, Hseu SS, Tsai SK, Lee TY. Effect of P-6 acupressure on prevention of nausea and vomiting after epidural morphine for post-cesarean section pain relief. Acta Anaesthesiol Scand. 1996;40(3):372-375. 
  2. Fan CF, Tanhui E, Joshi S, et al. Acupressure treatment for prevention of postoperative nausea and vomiting. Anesth Analg. 1997;84(4):821-825. 
  3. Gralla RJ. Antiemetic therapy. Semin Oncol. 1998;25(5):577-583.
  4. Shenkman Z, Holzman RS, Kim C, et al. Acupressure-acupuncture antiemetic prophylaxis in children undergoing tonsillectomy. Anesthesiology. 1999;90(5):1311-1316. 
  5. Lee A, Done ML. The use of nonpharmacologic techniques to prevent postoperative nausea and vomiting: A meta-analysis. Anesth Analg. 1999;88(6):1362-1369. 
  6. Alkaissi A, Stalnert M, Kalman S. Effect and placebo effect of acupressure (P6) on nausea and vomiting after outpatient gynaecological surgery. Acta Anaesthesiol Scand. 1999;43(3):270-274.
  7. Pearl ML, Fischer M, McCauley DL, et al. Transcutaneous electrical nerve stimulation as an adjunct for controlling chemotherapy-induced nausea and vomiting in gynecologic oncology patients. Cancer Nurs. 1999;22(4):307-311.
  8. Alberta Heritage Foundation for Medical Research (AHFMR). ReliefBand. Techscan. Edmonton, AB: Alberta Heritage Foundation for Medical Research (AHFMR); March 2000.
  9. Zarate E, Mingus M, White PF, et al. The use of transcutaneous acupoint electrical stimulation for preventing nausea and vomiting after laparoscopic surgery. Anesth Analg. 2001;92(3):629-635.
  10. Slotnick RN. Safe, successful nausea suppression in early pregnancy with P-6 acustimulation. J Reprod Med. 2001;46(9):811-814.
  11. White PF, Issioui T, Hu J, et al. Comparative efficacy of acustimulation (ReliefBand) versus ondansetron (Zofran) in combination with droperidol for preventing nausea and vomiting. Anesthesiology. 2002;97(5):1075-1081.
  12. Coloma M, White PF, Ogunnaike BO, et al. Comparison of acustimulation and ondansetron for the treatment of established postoperative nausea and vomiting. Anesthesiology. 2002;97(6):1387-1392.
  13. University of Texas at Austin, School of Nursing, Family Nurse Practitioner Program. Evaluation and management of nausea and vomiting in early pregnancy (less than or equal to 20 weeks gestation). Austin, TX: University of Texas at Austin, School of Nursing; May 2002.
  14. Rosen T, de Veciana M, Miller HS, et al. A randomized controlled trial of nerve stimulation for relief of nausea and vomiting in pregnancy. Obstet Gynecol.  2003;102(1):129-135.
  15. Jewell D, Young G. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. 2003;(4):CD000145.
  16. Treish I, Shord S, Valgus J, et al. Randomized double-blind study of the Reliefband as an adjunct to standard antiemetics in patients receiving moderately-high to highly emetogenic chemotherapy. Support Care Cancer. 2003;11(8):516-521.
  17. Miller KE, Muth ER. Efficacy of acupressure and acustimulation bands for the prevention of motion sickness. Aviat Space Environ Med. 2004;75(3):227-234.
  18. White PF, Hamza MA, Recart A, et al. Optimal timing of acustimulation for antiemetic prophylaxis as an adjunct to ondansetron in patients undergoing plastic surgery. Anesth Analg. 2005;100(2):367-372.
  19. American College of Obstetrics and Gynecology (ACOG). Nausea and vomiting of pregnancy. ACOG Practice Bulletin No.52. Washington, DC: ACOG; April 2004.
  20. Shiao SY, Dune LS. Metaanalyses of acustimulations: Effects on nausea and vomiting in postoperative adult patients. Explore (NY). 2006;2(3):202-215.
  21. Ezzo JM, Richardson MA, Vickers A, et al. Acupuncture-point stimulation for chemotherapy-induced nausea or vomiting. Cochrane Database Syst Rev. 2006;(2):CD002285.
  22. Habib AS, Itchon-Ramos N, Phillips-Bute BG, et al. Transcutaneous acupoint electrical stimulation with the ReliefBand for the prevention of nausea and vomiting during and after cesarean delivery under spinal anesthesia. Anesth Analg. 2006;102(2):581-584.
  23. Dune LS, Shiao SY. Metaanalysis of acustimulation effects on postoperative
    nausea and vomiting in children. Explore (NY). 2006;2(4):314-320.
  24. Arnberger M, Stadelmann K, Alischer P, et al. Monitoring of neuromuscular blockade at the P6 acupuncture point reduces the incidence of postoperative nausea and vomiting. Anesthesiology. 2007;107(6):903-908.
  25. Zheng LH, Sun H, Wang GN, et al. Effect of transcutaneous electrical acupoint stimulation on nausea and vomiting induced by patient controlled intravenous analgesia with tramadol. Chin J Integr Med. 2008;14(1):61-64.
  26. Allen TK, Habib AS. P6 stimulation for the prevention of nausea and vomiting associated with cesarean delivery under neuraxial anesthesia: A systematic review of randomized controlled trials. Anesth Analg. 2008;107(4):1308-1312.
  27. Frey UH, Scharmann P, Löhlein C, Peters J. P6 acustimulation effectively decreases postoperative nausea and vomiting in high-risk patients. Br J Anaesth. 2009;102(5):620-625.
  28. Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009;(2):CD003281.
  29. Larson JD, Gutowski KA, Marcus BC, et al. The effect of electroacustimulation on postoperative nausea, vomiting, and pain in outpatient plastic surgery patients: A prospective, randomized, blinded, clinical trial. Plast Reconstr Surg. 2010;125(3):989-994.
  30. Wang XQ, Yu JL, Du ZY, et al. Electroacupoint stimulation for postoperative nausea and vomiting in patients undergoing supratentorial craniotomy. J Neurosurg Anesthesiol. 2010;22(2):128-131.
  31. Matthews A, Dowswell T, Haas DM, et al. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. 2010;(9):CD007575.
  32. El-Deeb AM, Ahmady MS. Effect of acupuncture on nausea and/or vomiting during and after cesarean section in comparison with ondansetron. J Anesth. 2011;25(5):698-703.
  33. Silva MB, de Melo PR, de Oliveira NM, et al. Analgesic effect of transcutaneous electrical nerve stimulation after laparoscopic cholecystectomy. Am J Phys Med Rehabil. 2012;91(8):652-657
  34. Xu M, Zhou SJ, Jiang CC, et al. The effects of P6 electrical acustimulation on postoperative nausea and vomiting in patients after infratentorial craniotomy. J Neurosurg Anesthesiol. 2012;24(4):312-316.
  35. Lv JQ, Feng RZ, Li N. P6 acupoint stimulation for prevention of postoperative nausea and vomiting in patients undergoing craniotomy: Study protocol for a randomized controlled trial. Trials. 2013;14:153.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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